Okamoto Rubber Products Co., Ltd.

CLOSEOUT LETTER Okamoto Rubber Products Co., Ltd. MARCS-CMS 604564 — July 08, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Hideki Kaneuji Recipient Title President Okamoto Rubber Products Co., Ltd. 60/50, 60/51 Moo.19 Navanakorn Industrial Estate Zone 2 Klongnueng , Klongluang Pathum Thani 12120 Thailand Issuing Office: Center for Devices and Radiological Health United States Dear Hideki Kaneuji: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 604564), dated February 14, 2020. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely yours, /S/ Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: US AGENT: Mr. Yu Tadano Okamoto U.S.A., Inc. 3130 West Monroe Street Sandusky, Ohio 44870 yutadano@okamotousa.com Content current as of: 02/02/2022 Regulated Product(s) Medical Devices